BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE, VAMP

    MDR report key: 25231096 · Received May 20, 2026

    Report

    Report Number
    2015691-2026-15360
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Report Date
    May 20, 2026
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    KRA
    UDI-DI
    00690103011494
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: DXO, TRANSDUCER, PRESSURE, CATHETER TIP. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE PRESSURE MONITORING KIT THE TUBING SNAPPED WHILE DRAWING BLOOD FROM THE PATIENT. THE TUBING WAS QUICKLY CLAMPED OFF AND THE TUBING WAS CHANGED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108204 TRUWAVE, VAMP CATHETER, CONTINUOUS FLUSH KRA EDWARDS LIFESCIENCES DR PXAVMP NI 00690103011494

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown